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European agency begins fast-track study of experimental Covid treatment

The EU drug regulator said it had started a rolling review of sotrovimab, based on early results from an ongoing study into whether the treatment can prevent hospital admission or death in people who do not yet have severe Covid-19
Associated Press Reporters

The European Medicines Agency says it has begun an accelerated authorisation process for an experimental coronavirus treatment made by GlaxoSmithKline and Vir BioTechnology.

The EU drug regulator said it had started a rolling review of sotrovimab, based on early results from an ongoing study into whether the treatment can prevent hospital admission or death in people who do not yet have severe Covid-19.

The EMA said it had not yet received the complete data and cautioned it is “too early to draw any conclusions about the benefit-risk balance of the medication”.

Although the agency has approved four vaccines, there are few licensed treatments for coronavirus, especially any that might prevent people with mild Covid-19 from progressing to severe disease.

Sotrovimab is a monoclonal antibody, a lab-produced antibody intended to stimulate the immune system by reducing the ability of coronavirus’s spike protein to enter the body’s cells.

An emergency use authorisation for sotrovimab has also been submitted to regulators in the US and Canada.

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